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TBE Zone 2 PMS in Japan

TBE Zone 2 PMS in Japan

Recruiting
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Phase N/A

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Overview

The goal of this surveillance is to confirm the TBE device's safety and efficacy in patients treated with proximal landing in Zone 2 in the post-marketing period.

Eligibility

Inclusion Criteria:

  • Those who are suitable for use of TBE according to the Japan package insert.

\[Reference: Purpose of Use or Effects of TBE at the time of launch\] The GORE TAG Thoracic Branch Endoprosthesis is intended for use in patients with the following diseases with descending thoracic aortic lesions who fulfill anatomical requirements for treatment of such diseases while preserving blood flow to the left subclavian artery.

  • Thoracic aortic aneurysm,
  • Traumatic transection, and
  • Complicated Stanford type B aortic dissection (including dissecting aortic aneurysm) who have not responded to medical therapy.

Exclusion Criteria:

  • N/A

Study details
    Aneurysm Thoracic
    Dissection of Aorta
    Thoracic
    Trauma

NCT07049913

W.L.Gore & Associates

1 February 2026

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